Critical Illness, Dietary Modification, Hyperglycemia, Mechanical Ventilation Complication, Metabolic Stress Hyperglycemia
Conditions
Keywords
Critical illness, Hyperglycemia, Mechanical Ventilation, Enteral nutrition, T-Diet plus Diabet IR, Malnutrition, Insulin resistance, Metabolic stress
Brief summary
The aim of the study is to evaluate the beneficial effects of the administration of a complete diet rich in monounsaturated fatty acids (MUFA) and slow absorption carbohydrate in patients with stress hyperglycemia(T-Diet Plus Diabet IR). The main objective of this project is to evaluate blood glucose metabolic control, insulin requirements, insulin action resistance, lipid profile and to reduce infectious complications on mechanical ventilation ICU (intensive care unit) patients after the administration of a complete diet enriched in MUFA and slow absorption carbohydrates, without fructose.
Detailed description
Enteral formula administration designed for critically ill patients in metabolic stress situations, hyperglycemia and insulin resistance, formulated with monounsaturated fatty acids (MUFA), slowly absorption carbohydrates, omega-3 series polyunsaturated fatty acids (PUFA)enriched in eicosapentanoic acid (EPA) and docosahexaenoic acid (DHA), should be associated with an improvement in metabolic control, based on glucose levels reduction, and a decrease of insulin resistance infectious complications , mechanical ventilation days, ICU and hospital stay. All this against other two high protein conventional specific diets for hyperglycaemia patients.
Interventions
DIETARY_SUPPLEMENTT-Diet plus Diabet IR
Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
DIETARY_SUPPLEMENTISOSOURCE PROTEIN FIBRE
Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
DIETARY_SUPPLEMENTGLUCERNA SELECT
Group 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
Sponsors
Vegenat, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 admitted to intensive care units (ICU), with mechanical ventilation. * Patients receiving EN (enteral nutrition), for 5 days or more. * ICU stay in 48 hours or less, in the time of study inclusion. * Patients developing hyperglycemia in 48 hours of stay in ICU. * Nutritional support initiation within 48 hours of stay in ICU.
Exclusion criteria
* Patients with a life expectancy less than 48 hours. * Patients participating in another study. * Patients with APACHE II (Acute Physiology and Chronic Health Evaluation) less than 10. * Patients with BMI (body mass index) \> 40 Kg/m2. * Patients with Type I Diabetes. * Patients on chronic treatment with corticosteroid dose above 1 mg / kg / day of methylprednisolone or equivalent. * Pregnant patients. * Patients taking lipid-lowering drugs. * Acute renal failure patients, defined by the following criteria: * Serum creatinine greater than 4 mg / dL with acute rise higher than 0.5 mg / dl / day. * Serum creatinine higher than 3 mg/dL. * Diuresis \< 0.3 ml/kg/h during 24 hours. * Anury for 12 hours or more. * Hepatic failure patients, defined by the following parameters: * Serious acute hepatic failure. * Child degrees B-C. * Serum bilirubin higher than 3 mg/dL. * Patients with parenteral nutrition during study inclusion. * Informed consent absence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 | 28 days post-admission | This table shows the rates of: * Controls analysis on 80-150 mg/dL: optimal level of glycemia rate. * Hypoglycemia (50-80 mg/dL): moderate hypoglycemia rate. * Hypoglycemia (\<50 mg/dL): severe hypoglycemia episodes rate. |
| Measure of Biochemical Parameters and Evaluation of Infectious Complications 3 | 28 days post-admission | The variables recorded related to number of capillary glycemia measurements are provided in this table |
| Measure of Biochemical Parameters and Evaluation of Infectious Complications 4 | 28 days post-admission | The variables recorded related to the number of measurements per patient per day are provided in this table |
| Measure of Biochemical Parameters and Evaluation of Infectious Complications 5 | 28 days post-admission | The variables recorded related to Glycemic CV (%) are provided in this table: * Glycemic Coeficient of variation (%) after 28 days in ICU * Glycemic Coeficient of variation (%) after 7 days in ICU. |
| Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1 | 28 days post-admission | This table shows the number of capillary glycemia measurements |
| Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | 28 days post-admission | The variables recorded related to glycemic control in mg/dL are provided in this table. |
| Measure of Biochemical Parameters and Evaluation of Infectious Complications 2 | 28 days post-admission | The variables recorded related to administered insulin in IU/day are provided in this table |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Critical Ill Patients Progress During Hospital Stay 2 | 28 days post-admission | Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table |
| Assessment of Critical Ill Patients Progress During Hospital Stay 3 | 28 days post-admission | The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table. |
| Assessment of Critical Ill Patients Progress During Hospital Stay 4 | 100 days of treatment | Number of participants with infectious complications is provided in this table. |
| Assessment of Critical Ill Patients Progress During Hospital Stay 1 | 100 days of treatment | Infectious complication incidence rate per 100 days of treatment are provided in this table. |
Countries
Spain
Participant flow
Recruitment details
This study examines whether a high-protein diabetes-specific formula reduces insulin needs, improves glycemic control and reduces ICU-adquired infection in critically ill, hyperglycemic patients on mechanical ventilation (MV)
Pre-assignment details
The study was performed over the period April 2010 to May 2012. A website was constructed to record data and to randoize patients to each EN formula. Data were collected online using an electronic case report form.
Participants by arm
| Arm | Count |
|---|---|
| DIABA HP Patients of this group received new-generation diabetes-specific high-protein formula (Diaba HP®, Vegenat, Badajoz, Spain); as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric
Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
DIABA HP group received, 25 kcal / kg/ day for 28 days, via gastric or transpyloric. | 52 |
| ISOSOURCE PROTEIN FIBRE Patients of this group will received ISOSOURCE PROTEIN FIBRE (Nestlé Health Science, barcelona, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.
ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric. | 53 |
| GLUCERNA SELECT Patients of this group will receive GLUCERNA SELECT (Abbott Nutrition, Madrid, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.
GLUCERNA SELECT group received 25 kcal / kg / day for 28 days, via gastric or transpyloric. | 52 |
| Total | 157 |
Baseline characteristics
| Characteristic | DIABA HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT | Total |
|---|---|---|---|---|
| Age, Continuous | 57 years | 60 years | 58 years | 58 years |
| APACHE II | 17 units on a scale | 19 units on a scale | 19 units on a scale | 19 units on a scale |
| Body Mass Index (BMI) | 26 kg/m^2 | 26 kg/m^2 | 26 kg/m^2 | 26 kg/m^2 |
| Calorie requirements | 1690.4 kcal/day STANDARD_DEVIATION 384.9 | 1707.1 kcal/day STANDARD_DEVIATION 275.4 | 1728.2 kcal/day STANDARD_DEVIATION 309.2 | 1708.6 kcal/day STANDARD_DEVIATION 323.2 |
| Capillary glucose level | 148.8 mg/dL STANDARD_DEVIATION 38.8 | 149.9 mg/dL STANDARD_DEVIATION 38.9 | 151.5 mg/dL STANDARD_DEVIATION 39.23 | 150 mg/dL STANDARD_DEVIATION 38.98 |
| C-peptide | 4.61 ng/mL STANDARD_DEVIATION 3.24 | 4.49 ng/mL STANDARD_DEVIATION 2.92 | 4.27 ng/mL STANDARD_DEVIATION 3.67 | 4.46 ng/mL STANDARD_DEVIATION 3.28 |
| Diagnostic group: Medical | 32 participants | 36 participants | 30 participants | 98 participants |
| Diagnostic group: Surgery | 7 participants | 8 participants | 7 participants | 22 participants |
| Diagnostic group: Trauma | 13 participants | 9 participants | 15 participants | 37 participants |
| HbA1c | 6.34 percentaje of glycated hemoglobin STANDARD_DEVIATION 1.38 | 5.76 percentaje of glycated hemoglobin STANDARD_DEVIATION 0.95 | 6.07 percentaje of glycated hemoglobin STANDARD_DEVIATION 1.39 | 6.1 percentaje of glycated hemoglobin STANDARD_DEVIATION 1.24 |
| HOMA2 %B | 102.6 % of beta cell function STANDARD_DEVIATION 57.81 | 110.5 % of beta cell function STANDARD_DEVIATION 74.34 | 96.55 % of beta cell function STANDARD_DEVIATION 85.09 | 103.21 % of beta cell function STANDARD_DEVIATION 72.41 |
| HOMA2 IR | 2.94 units on a scale STANDARD_DEVIATION 4.19 | 2.48 units on a scale STANDARD_DEVIATION 2.76 | 3.38 units on a scale STANDARD_DEVIATION 2.37 | 2.93 units on a scale STANDARD_DEVIATION 3.11 |
| HOMA2 %S | 79.12 % of insulin sensitivity STANDARD_DEVIATION 75.2 | 69.6 % of insulin sensitivity STANDARD_DEVIATION 48.7 | 68.09 % of insulin sensitivity STANDARD_DEVIATION 66.9 | 72.27 % of insulin sensitivity STANDARD_DEVIATION 63.6 |
| Infection | 13 participants | 15 participants | 8 participants | 36 participants |
| Insulinemia | 21.59 microU/mL STANDARD_DEVIATION 36.06 | 17.39 microU/mL STANDARD_DEVIATION 23.77 | 19.15 microU/mL STANDARD_DEVIATION 20.5 | 19.38 microU/mL STANDARD_DEVIATION 26.78 |
| Noninsulin-dependent diabetes | 11 participants | 7 participants | 12 participants | 30 participants |
| Plasma glucose level | 152.1 mg/dL STANDARD_DEVIATION 54.6 | 147.01 mg/dL STANDARD_DEVIATION 55.93 | 152.1 mg/dL STANDARD_DEVIATION 57.12 | 150.4 mg/dL STANDARD_DEVIATION 55.88 |
| Sex: Female, Male Female | 15 Participants | 10 Participants | 13 Participants | 38 Participants |
| Sex: Female, Male Male | 37 Participants | 43 Participants | 39 Participants | 119 Participants |
| SOFA score | 8 units on a scale | 7 units on a scale | 7 units on a scale | 8 units on a scale |
| Start of EN | 23.4 hours | 25.1 hours | 26.7 hours | 25.1 hours |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 53 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 53 | 0 / 52 |
Outcome results
Primary
Measure of Biochemical Parameters and Evaluation of Infectious Complications 1
The variables recorded related to glycemic control in mg/dL are provided in this table.
Time frame: 28 days post-admission
Population: Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose \>126 mg/dL after fasting or\>200 mg/dL otherwise) in the first 48 h of ICU admission.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Plasma glucose level (mg/dL) | 138.6 mg/dL | Standard Deviation 39.1 |
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Capillary glucose level (mg/dL) | 146.1 mg/dL | Standard Deviation 45.8 |
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Mean capillary glycemia on ICU day 1 (mg/dL) | 147.5 mg/dL | Standard Deviation 40.2 |
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Peak glucose level (mg/dL) | 181.3 mg/dL | Standard Deviation 52 |
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Glycemic variability SD (mg/dL) (ICU days 1-28) | 33.6 mg/dL | Standard Deviation 18.4 |
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Glycemic variability SD (mg/dL) (ICU days 1-7) | 43.2 mg/dL | Standard Deviation 4.9 |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Glycemic variability SD (mg/dL) (ICU days 1-7) | 68.5 mg/dL | Standard Deviation 13.5 |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Plasma glucose level (mg/dL) | 146.1 mg/dL | Standard Deviation 49.9 |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Peak glucose level (mg/dL) | 193.6 mg/dL | Standard Deviation 74.6 |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Glycemic variability SD (mg/dL) (ICU days 1-28) | 49.1 mg/dL | Standard Deviation 21.5 |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Capillary glucose level (mg/dL) | 155.3 mg/dL | Standard Deviation 63.6 |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Mean capillary glycemia on ICU day 1 (mg/dL) | 160 mg/dL | Standard Deviation 55.5 |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Capillary glucose level (mg/dL) | 150.1 mg/dL | Standard Deviation 41.9 |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Mean capillary glycemia on ICU day 1 (mg/dL) | 145.6 mg/dL | Standard Deviation 46.6 |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Glycemic variability SD (mg/dL) (ICU days 1-7) | 42.5 mg/dL | Standard Deviation 2.7 |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Peak glucose level (mg/dL) | 191.3 mg/dL | Standard Deviation 65.8 |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Plasma glucose level (mg/dL) | 143.9 mg/dL | Standard Deviation 45.9 |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 | Glycemic variability SD (mg/dL) (ICU days 1-28) | 41.1 mg/dL | Standard Deviation 9.3 |
Primary
Measure of Biochemical Parameters and Evaluation of Infectious Complications 2
The variables recorded related to administered insulin in IU/day are provided in this table
Time frame: 28 days post-admission
Population: Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose \>126 mg/dL after fasting or\>200 mg/dL otherwise) in the first 48 h of ICU admission.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 2 | 19.1 IU/day | Standard Deviation 13.1 |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 2 | 23.7 IU/day | Standard Deviation 40.1 |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 2 | 20.3 IU/day | Standard Deviation 30.1 |
Primary
Measure of Biochemical Parameters and Evaluation of Infectious Complications 3
The variables recorded related to number of capillary glycemia measurements are provided in this table
Time frame: 28 days post-admission
Population: Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose \>126 mg/dL after fasting or\>200 mg/dL otherwise) in the first 48 h of ICU admission.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 3 | 3605 Capillary glycemia measurements |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 3 | 3523 Capillary glycemia measurements |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 3 | 3557 Capillary glycemia measurements |
Primary
Measure of Biochemical Parameters and Evaluation of Infectious Complications 4
The variables recorded related to the number of measurements per patient per day are provided in this table
Time frame: 28 days post-admission
Population: Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose \>126 mg/dL after fasting or\>200 mg/dL otherwise) in the first 48 h of ICU admission.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 4 | 5.7 Measurements per patient/day | Standard Deviation 3.4 |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 4 | 5.81 Measurements per patient/day | Standard Deviation 3.2 |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 4 | 5.46 Measurements per patient/day | Standard Deviation 2.9 |
Primary
Measure of Biochemical Parameters and Evaluation of Infectious Complications 5
The variables recorded related to Glycemic CV (%) are provided in this table: * Glycemic Coeficient of variation (%) after 28 days in ICU * Glycemic Coeficient of variation (%) after 7 days in ICU.
Time frame: 28 days post-admission
Population: Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose \>126 mg/dL after fasting or\>200 mg/dL otherwise) in the first 48 h of ICU admission.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 5 | Glycemic CV (%) (ICU days 1-28) | 27.9 percentage of Glycemic CV | Standard Deviation 5.8 |
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 5 | Glycemic CV (%) (ICU days 1-7) | 28.3 percentage of Glycemic CV | Standard Deviation 1.9 |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 5 | Glycemic CV (%) (ICU days 1-28) | 32.4 percentage of Glycemic CV | Standard Deviation 11.2 |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 5 | Glycemic CV (%) (ICU days 1-7) | 42.6 percentage of Glycemic CV | Standard Deviation 8.2 |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 5 | Glycemic CV (%) (ICU days 1-28) | 27.8 percentage of Glycemic CV | Standard Deviation 5.2 |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 5 | Glycemic CV (%) (ICU days 1-7) | 28.4 percentage of Glycemic CV | Standard Deviation 2.1 |
Primary
Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2
This table shows the rates of: * Controls analysis on 80-150 mg/dL: optimal level of glycemia rate. * Hypoglycemia (50-80 mg/dL): moderate hypoglycemia rate. * Hypoglycemia (\<50 mg/dL): severe hypoglycemia episodes rate.
Time frame: 28 days post-admission
Population: Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose \>126 mg/dL after fasting or\>200 mg/dL otherwise) in the first 48 h of ICU admission.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 | Hypoglycemia (50-80 mg/dL) | 1.48 % of capillary glycemia measurements |
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 | Controls on 80-150 mg/dL | 59 % of capillary glycemia measurements |
| Diaba HP | Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 | Hypoglycemia (<50 mg/dL) | 0 % of capillary glycemia measurements |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 | Hypoglycemia (50-80 mg/dL) | 3.63 % of capillary glycemia measurements |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 | Controls on 80-150 mg/dL | 57.6 % of capillary glycemia measurements |
| ISOSOURCE PROTEIN FIBRE | Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 | Hypoglycemia (<50 mg/dL) | 0.11 % of capillary glycemia measurements |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 | Controls on 80-150 mg/dL | 59.59 % of capillary glycemia measurements |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 | Hypoglycemia (<50 mg/dL) | 0.02 % of capillary glycemia measurements |
| GLUCERNA SELECT | Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 | Hypoglycemia (50-80 mg/dL) | 1.25 % of capillary glycemia measurements |
Primary
Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1
This table shows the number of capillary glycemia measurements
Time frame: 28 days post-admission
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diaba HP | Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1 | 3605 number of capillary glycemia measurement |
| ISOSOURCE PROTEIN FIBRE | Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1 | 3523 number of capillary glycemia measurement |
| GLUCERNA SELECT | Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1 | 3557 number of capillary glycemia measurement |
Secondary
Assessment of Critical Ill Patients Progress During Hospital Stay 1
Infectious complication incidence rate per 100 days of treatment are provided in this table.
Time frame: 100 days of treatment
Population: Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose \>126 mg/dL after fasting or\>200 mg/dL otherwise) in the first 48 h of ICU admission.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diaba HP | Assessment of Critical Ill Patients Progress During Hospital Stay 1 | 22 percentage of patients with infection |
| ISOSOURCE PROTEIN FIBRE | Assessment of Critical Ill Patients Progress During Hospital Stay 1 | 24 percentage of patients with infection |
| GLUCERNA SELECT | Assessment of Critical Ill Patients Progress During Hospital Stay 1 | 24 percentage of patients with infection |
Secondary
Assessment of Critical Ill Patients Progress During Hospital Stay 2
Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table
Time frame: 28 days post-admission
Population: Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose \>126 mg/dL after fasting or\>200 mg/dL otherwise) in the first 48 h of ICU admission.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diaba HP | Assessment of Critical Ill Patients Progress During Hospital Stay 2 | Primary bloodstream infection | 3 participants |
| Diaba HP | Assessment of Critical Ill Patients Progress During Hospital Stay 2 | Catether-related bloodstream infection | 1 participants |
| Diaba HP | Assessment of Critical Ill Patients Progress During Hospital Stay 2 | Urinary tract infection | 1 participants |
| ISOSOURCE PROTEIN FIBRE | Assessment of Critical Ill Patients Progress During Hospital Stay 2 | Primary bloodstream infection | 1 participants |
| ISOSOURCE PROTEIN FIBRE | Assessment of Critical Ill Patients Progress During Hospital Stay 2 | Catether-related bloodstream infection | 1 participants |
| ISOSOURCE PROTEIN FIBRE | Assessment of Critical Ill Patients Progress During Hospital Stay 2 | Urinary tract infection | 1 participants |
| GLUCERNA SELECT | Assessment of Critical Ill Patients Progress During Hospital Stay 2 | Catether-related bloodstream infection | 2 participants |
| GLUCERNA SELECT | Assessment of Critical Ill Patients Progress During Hospital Stay 2 | Urinary tract infection | 1 participants |
| GLUCERNA SELECT | Assessment of Critical Ill Patients Progress During Hospital Stay 2 | Primary bloodstream infection | 3 participants |
Secondary
Assessment of Critical Ill Patients Progress During Hospital Stay 3
The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.
Time frame: 28 days post-admission
Population: Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose \>126 mg/dL after fasting or\>200 mg/dL otherwise) in the first 48 h of ICU admission.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diaba HP | Assessment of Critical Ill Patients Progress During Hospital Stay 3 | Tracheobonchitis incidence rate | 7 number of new cases per 1000 days |
| Diaba HP | Assessment of Critical Ill Patients Progress During Hospital Stay 3 | Ventilator-associated pneumonia | 8 number of new cases per 1000 days |
| ISOSOURCE PROTEIN FIBRE | Assessment of Critical Ill Patients Progress During Hospital Stay 3 | Ventilator-associated pneumonia | 10 number of new cases per 1000 days |
| ISOSOURCE PROTEIN FIBRE | Assessment of Critical Ill Patients Progress During Hospital Stay 3 | Tracheobonchitis incidence rate | 10 number of new cases per 1000 days |
| GLUCERNA SELECT | Assessment of Critical Ill Patients Progress During Hospital Stay 3 | Ventilator-associated pneumonia | 6 number of new cases per 1000 days |
| GLUCERNA SELECT | Assessment of Critical Ill Patients Progress During Hospital Stay 3 | Tracheobonchitis incidence rate | 7 number of new cases per 1000 days |
Secondary
Assessment of Critical Ill Patients Progress During Hospital Stay 4
Number of participants with infectious complications is provided in this table.
Time frame: 100 days of treatment
Population: Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose \>126 mg/dL after fasting or\>200 mg/dL otherwise) in the first 48 h of ICU admission.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diaba HP | Assessment of Critical Ill Patients Progress During Hospital Stay 4 | 18 participants |
| ISOSOURCE PROTEIN FIBRE | Assessment of Critical Ill Patients Progress During Hospital Stay 4 | 23 participants |
| GLUCERNA SELECT | Assessment of Critical Ill Patients Progress During Hospital Stay 4 | 23 participants |